Open Label Immunotherapy of Myoma (V3-myoma)

Open Label Phase II Clinical Trial of Myoma Immunotherapy

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

Study Overview

• Status: Unknown
• Conditions: Leiomyoma; Fibroma; Myoma;Uterus; Fibroid Uterus
• Intervention / Treatment: Biological: V3-Myoma

Detailed Description

Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mongolia
  • Ulaanbaatar, Mongolia
    • Recruiting
    • Immunitor LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -

Exclusion Criteria:

other gynecological diseases not related to myoma hysterectomy

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm receiving V3-Myoma; A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues	Biological: V3-Myoma; Once daily oral pill of V3-Myoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tumor size compared to baseline	This parameter will be evaluated by pelvic examination and transvaginal ultrasonography	Once monthly for three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in bleeding pattern at and between menstruations	Self-evaluated by patient	During and between periods for three months
Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any	Self evaluated by patient	3 months
Changes in frequent urination or difficulty in emptying the bladder or constipation	Self evaluated by patient	3 months

Collaborators and Investigators

• Sponsor: Immunitor LLC

Publications and helpful links

Helpful Links

• review on oral vaccines

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 26, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Fibrous Tissue; Myoma; Leiomyoma; Myofibroma; Fibroma
• Other Study ID Numbers: Myoma01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Upon study completion the data will be available in peer-reviewed publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No